Background: Bone and Joint Infections (BJIs) present with non-specific symptoms that may include pain, swelling, and fever and are associated with high morbidity and significant risk of mortality. BJIs can be caused by a variety of bacteria and fungi, including anaerobes and microorganisms that can be challenging to culture or identify by traditional microbiological methods. Clinicians currently rely primarily on culture to identify the pathogen(s) responsible for infection. The BIOFIRE® FILMARRAY® Bone and Joint Infection (BJI) Panel (BioFire Diagnostics, Salt Lake City, UT) was designed to detect 15 gram-positive (seven anaerobes) and 14 gram-negative bacteria (one anaerobe), two yeast, and eight antimicrobial resistance (AMR) genes from synovial fluid specimens in about an hour. The objective of this study is to evaluate the performance of an Investigational Use Only (IUO) version of the BIOFIRE® BJI Panel compared to various reference methods.
Materials/methods: Remnant synovial fluid specimens, which had been collected for routine clinical care at 13 study sites in the US and Europe, are undergoing testing using an IUO version of the BIOFIRE® BJI Panel. Performance is determined by comparison to Standard of Care (SoC) testing consisting of bacterial culture at each study site (performed according to each site’s routine procedures).
Results: To date, 336 specimens (out of an anticipated 1,500) have been collected and tested with the panel. The majority are from knee joints (71.7%) and arthrocentesis (86.6%) is the most common collection method. Compared to SoC culture, overall sensitivity is 90% and specificity is 99.8%. Testing is ongoing.
Conclusions: The BIOFIRE® BJI Panel is a sensitive, specific, and robust test for rapid detection of a wide range of analytes in synovial fluid specimens. The number of microorganisms and resistance markers included in the BIOFIRE® BJI Panel, together with a reduced time-to-result and increased diagnostic yield compared to culture, is expected to aid in the timely diagnosis and appropriate management of BJIs.
Data presented are from assays that have not been cleared or approved for diagnostic use.